On January 20, 2021, the National Institute for Health and Disability Insurance (INAMI-RIZIV) announced the reimbursement pathway for health apps. Health apps can now reach level M3 of the validation pyramid.
The mHealthBelgium platform, created in 2018, is managed by the Belgian Federation of the medical technology industry (beMedTech) and the Belgian Federation of Technology Companies (Agoria). Health apps reach level M1 of the platform when they meet the basic requirements (i.e., recognition as a medical device (CE marking) and compliance with European data protection regulations, as well as product notification in the Federal Agency for Medicines and Health Products (FAMHP) database).
Level M2 can be achieved if a health app meets certain quality criteria in identification and authentication of a user, verification of the therapeutic relationship and informed consent, interoperability, and data protection. Currently, there are seven health apps at the level M2 of the validation pyramid.
Once the first two levels are achieved, the app can be submitted for reimbursement (level M3). The framework to obtain reimbursement (achieving level M3 of the validation pyramid) is now functioning. Only after achieving level M3 of the pyramid, the health app is reimbursed.
The full details in French can be found here and here.
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